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The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

The provided document is a 510(k) premarket notification for the Choice Spine Laminoplasty™ Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven device.

Instead, for a medical device like a spinal fixation system, "acceptance criteria" are generally met through a combination of:

• Design Specifications and Material Compliance: Ensuring the device is manufactured from medical-grade materials to specific dimensions and tolerances.
• Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
• Mechanical Performance Testing: Evaluating the device's strength, durability, and resistance to various forces it might experience in vivo.
• Sterilization Validation: Ensuring the device can be sterilized effectively without compromising its integrity.
• Clinical Performance (often through substantial equivalence): Demonstrating that the device performs as intended and is as safe and effective as legally marketed predicate devices.

The document primarily focuses on the Substantial Equivalence claim, which is the cornerstone for 510(k) clearance.

Here's an analysis based on the provided text, addressing your points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are derived from recognized standards and comparative performance to predicates, rather than a specific set of diagnostic metrics.

2. Sample Size Used for the Test Set and Data Provenance

For a spinal fixation system seeking 510(k) clearance, the "test set" primarily refers to the physical devices (prototypes or production samples) subjected to mechanical and material testing, not a dataset of patient images or outcomes.

• Sample Size for Mechanical Testing: Not explicitly stated in the document. These tests (ASTM F2193, ASTM F543) typically require a specific number of samples (e.g., n=5 or n=6) to establish statistical significance for material properties and device performance.
• Data Provenance: The mechanical test data would be generated in a lab setting, typically by the manufacturer or a contract testing facility, specifically for this device design. It's not "retrospective or prospective" in the sense of clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of medical device submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where subjective human interpretation is being evaluated or augmented. For a spinal implant, mechanical tests use objective physical measurements against established standards, and "ground truth" for clinical safety and effectiveness is largely inferred from substantial equivalence to devices with a known clinical history.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies or when interpreting diagnostic images to resolve discrepancies among expert readers and establish a reference standard. For mechanical testing, the results are quantitative measures from instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted or is not detailed in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices or AI tools to assess reader performance with and without AI assistance. This device is a physical implant, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical spinal implant, not an algorithm or AI product. Its performance is evaluated through mechanical testing and comparison to predicate devices, not algorithm-only performance.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily established through:

• Recognized Standards: Specific ASTM standards (F2193, F543) define the methodologies and expected performance characteristics for spinal fixation devices. Compliance with these standards forms a "physical ground truth."
• Predicate Device Performance: The established safety and effectiveness of the identified predicate devices (DePuy Mountaineer, Synthes Arch Fixation System, Medtronic CENTERPIECE Plate Fixation System, Spectrum Spine Laminoplasty Plating System) serve as a de-facto "clinical ground truth" for substantial equivalence. The new device is accepted if it performs similarly or better in mechanical tests and has similar indications and materials.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for a hardware device, no ground truth needed to be established for it.

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